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About Shire

We're with you.

Longer than any other manufacturer, Shire* has been a reliable and consistent supplier of Ig treatment.¹

Through Growth and Transition

Shire's* investments in plasma treatment processing have grown from $614 million to $1.2 billion in recent years, and Shire is committed to continued investment in the future.¹

With 60 state-of-the-art plasma collection centers, Shire collects nearly 4 million liters of source plasma each year to meet the needs of those who rely on plasma-based treatment.^2,3 Shire also has the largest fractionation capacity among all plasma manufacturers and plans to build a new facility that will add up to 3 million liters of fractionation capacity annually when fully functional.¹

With Education and Support

Shire offers unprecedented support and a wealth of educational resources, created with the help of patients, caregivers, and healthcare professionals from the community. Support is offered without charge to patients and caregivers, regardless of treatment.

Learn more about MyIgSource.

Yesterday, Today, and Tomorrow

Shire plc* became a leader in plasma fractionation in 1941 and is the only company that has been continuously processing IVIG for 25 years.⁴ Our aim is to provide the highest quality products and programs that advance patient care globally and enable the achievement of outcomes through innovation, science, and technology.

*Shire plc bought Baxalta Incorporated in 2016. Baxalta Incorporated was formerly the BioScience Division at Baxter International Inc. and continues to provide those same treatments and products.

References: 1. Baxter International Inc. 2012 Annual Report. 2. BioLife Press Kit. //biolifeplasma.com/downloads/biolife-press-kit.pdf. Accessed June 24, 2013. 3. Data on file (BioLife Directory). Baxter Healthcare Corporation. 4. Marketing Research Bureau. The plasma proteins market in the United States 2011. Published June 2012.

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What is GAMMAGARD LIQUID?

GAMMAGARD LIQUID is a ready-to-use liquid medicine that is given in a vein (intravenously) or under the skin (subcutaneously) to treat primary immunodeficiency (PI) in people 2 years and older and given in a vein to treat multifocal motor neuropathy (MMN) in adults.

IMPORTANT SAFETY INFORMATION

What is the most important information that I should know about GAMMAGARD LIQUID?

GAMMAGARD LIQUID can cause the following serious reactions:

Severe allergic reactions causing difficulty in breathing or skin rashes
Decreased kidney function or kidney failure
Blood clots in the heart, brain, lungs or elsewhere in the body
Severe headache, drowsiness, fever, painful eye movements, or nausea and vomiting
Dark colored urine, swelling, fatigue, or difficulty breathing

Who should not use GAMMAGARD LIQUID?

Do not use GAMMAGARD LIQUID if you:

Have had a severe allergic reaction to immune globulin or other blood products.
Have a condition called selective (or severe) immunoglobulin A (IgA) deficiency.

What should I avoid while taking GAMMAGARD LIQUID?

GAMMAGARD LIQUID can make vaccines (like measles/mumps/rubella or chickenpox vaccines) not work as well for you. Before you get any vaccines, tell your healthcare provider (HCP) that you take GAMMAGARD LIQUID.
Tell your HCP if you are pregnant, or plan to become pregnant, or if you are nursing.

What are the possible or reasonably likely side effects of GAMMAGARD LIQUID?

GAMMAGARD LIQUID can cause serious side effects. If any of the following problems occur after starting GAMMAGARD LIQUID, stop the infusion immediately and contact your HCP or call emergency services:

Hives, swelling in the mouth or throat, itching, trouble breathing, wheezing, fainting or dizziness. These could be signs of a serious allergic reaction.
Bad headache with nausea, vomiting, stiff neck, fever, and sensitivity to light. These could be signs of irritation and swelling of the lining around your brain.
Reduced urination, sudden weight gain, or swelling in your legs. These could be signs of a kidney problem.
Pain, swelling, warmth, redness, or a lump in your legs or arms. These could be signs of a blood clot.
Brown or red urine, fast heart rate, yellow skin or eyes. These could be signs of a liver or blood problem.
Chest pain or trouble breathing, or blue lips or extremities. These could be signs of a serious heart or lung problem.
Fever over 100°F. This could be a sign of an infection.

The following one or more possible reactions may occur at the site of infusion of GAMMAGARD LIQUID for PI, generally go away within a few hours, and are less likely after the first few infusions:

Mild or moderate pain
Swelling
Itching
Redness
Bruising
Warmth

During the infusion of GAMMAGARD LIQUID for PI, look out for the first signs of the following common side effects:

Headache
Migraine
Fever
Fatigue
Itching
Rashes/hives
Cough
Chest pain/tightness

Chills/shaking chills
Dizziness
Nausea/vomiting
Faster heart rate
Upper abdominal pain
Increased blood pressure
Muscle cramps
Sore throat

The most common side effects of GAMMAGARD LIQUID for MMN include:

Headache
Chest discomfort
Muscle spasms
Muscular weakness

Nausea
Sore throat
Ear pain
Pain in hands or feet

These are not all the possible side effects. Talk to your HCP about any side effect that bothers you or that does not go away.

For additional safety information, click for Information For Patients and discuss with your HCP.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Gammagard Liquid MyIgCoPayCard Program Terms and Conditions

This manufacturer's coupon program is not valid for prescriptions reimbursed, in whole or in part, by Medicaid, Medicare, Medigap, VA, DoD, TRICARE, or any other federal or state healthcare programs, including state pharmaceutical assistance programs, and where prohibited by the health insurance provider or by law

Shire's MyIgCoPayCard program provides a maximum total benefit of $5,000 for eligible out-of-pocket costs and expires 12 months from date of activation. Eligible costs include deductible, copayment, and co-insurance costs for eligible Shire IG (Immunoglobulin) products. Non-medication expenses, such as ancillary supplies or administration-related costs, are not eligible.

To be eligible, patients must: 1. be starting or receiving treatment with (and have current prescription for) an eligible Shire IG product with an ICD-10 for a diagnosis of Primary Immunodeficiency; and 2. have commercial insurance that covers medication costs for prescribed Shire IG product and allows for CoPay assistance; and 3. be two (2) years old or older.

Acceptance of this offer must be consistent with the terms of benefits provided by patient's health insurance provider.

Offer limited to one card per person and may not be combined with any other coupon, discount, prescription savings card, rebate, free trial, patient assistance, or other offer.

This program is only valid for residents of the United States.

Shire reserves the right to change or discontinue this program at any time without notice.

This is not health insurance.

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Add to patient instructions:

If your insurance situation changes, it is your responsibility to notify MyIgSource's CoPay assistance program.

SHIRE and the Shire Logo are registered trademarks of Shire Pharmaceutical Holdings Ireland Limited or its affiliates. Gammagard Liquid is a trademark or registered trademark of Baxalta Incorporated, a wholly owned, indirect subsidiary of Shire plc.

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Please expand for Indication and Important Safety Information.

IMPORTANT SAFETY INFORMATION

What is the most important information that I should know about GAMMAGARD LIQUID?

GAMMAGARD LIQUID can cause the following serious reactions: severe allergic reactions causing difficulty in breathing or skin rashes; decreased kidney function or kidney failure; blood clots in the heart, brain, lungs or elsewhere in the body; severe headache, drowsiness, fever, painful eye movements, or nausea and vomiting; dark colored urine, swelling, fatigue, or difficulty breathing.